Wireless enabled bags and containers

ABSTRACT

The present invention provides a process for incorporating a wireless device into a plastic container as part of the steps of manufacturing the container. The plastic container can be a flexible plastic bag and are formed of one or more sheets, generally two or more sheets of plastic film or a rigid plastic container such as a tub or tote. The bags are formed by sealing together adjacent edge portions of each film layer. One embodiment of the present invention is to incorporate a wireless device between the edge portions of the film(s) before or during sealing so that the wireless device becomes permanently sealed into the film material but is isolated from both the bag interior and the outside environment. Another embodiment is to incorporate the wireless device onto or into a plastic component that is sealed to the container, such as a nipple or port, so that the wireless device becomes permanently sealed to the container but is isolated from both the container interior and the outside environment.

CROSS-REFERENCED TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.12/456,639 filed Jun. 19, 2009, which claims the benefit of U.S.Provisional Patent Application No. 61/134,169, filed on Jul. 7, 2008,the entire contents of which are incorporated by reference herein.

The present invention relates to a process and device for incorporatingwireless enabled devices permanently into disposable bags andcontainers. More particularly, it relates to the incorporation of awireless device, such as a RFID tag, into the structure of the bag orcontainer or a component of the bag or container that is permanentlyattached to the bag or container.

BACKGROUND OF THE INVENTION

The use of identification and preferably active or interactiveidentification devices is becoming a popular item for severalbusinesses. These range from simply bar codes to three dimensional barcodes to more recently wireless devices such as read only or read-writeRFID chips (active or interactive systems).

In many products, the wireless device is simply attached to the cartonin which it is shipped and is useful only during storage and transport.

More recently, the wireless devices have begun to be attached to theproduct itself so that it can be enquired any time during its life.

On plastic parts such as tubing and filters, various methods have beensuggested for attaching such a tag. These include molding the tag onto acollar on the tubing or to mold the tag as part of the tubing or filterhousing. In other applications, the use of an adhesive patch or pouch tobond the tag to the product has been suggested. The use of a spiral wrapof tape to contain the tag has also been suggested. Lastly, the use ofstraps or “dog tags” containing the tag that are then attached to thedevice has been suggested.

Many of these approaches such as molding as part of the formation of theplastic material will not work for plastic films used to make bags andcontainers. The film manufacturing process is difficult and theplacement of the tag in the film as it is being made is near impossible.Additionally as films are used to make different sized bags, theplacement of the tags would have to be far enough apart to accomplishthis while providing a tag for each container. This leads to waste ofplastic or of the tags themselves in making the different sized bags.

Other means such as the pouch, strap or dog tags all occur as a separatestep and there is the risk that they may be forgotten. Additionally,they are an additional processing step and require the use for anadditional element (pouch or patch, strap or dog tag).

What is needed is a process for incorporating the tag as part of themanufacture process of the container and a device having such a tagfeature.

SUMMARY OF THE INVENTION

The present invention provides a process for incorporating a wirelessdevice into a plastic container (be it a bag or rigid plastic container)as part of the steps of manufacturing the container.

Most plastic containers are bags and are formed of one or more sheets,generally two or more sheets of plastic film. The bags are formed bysealing together adjacent edge portions of each film layer(s). Oneembodiment of the present invention is to incorporate a wireless devicebetween the edge portions of the film(s) before sealing so that thedevice becomes permanently sealed into the film but is isolated fromboth the bag interior and the outside environment. The wireless devicemay be adhered to a film surface if desired.

Another embodiment is to incorporate the wireless device into a plasticcomponent that is sealed to the container, such as a nipple or port, sothat the device becomes permanently sealed onto or into the plasticcomponent's material but is isolated from both the bag interior and theoutside environment. The wireless device may be adhered to a surface ofthe plastic component, overmolded onto the plastic component or moldedinto the component during its manufacture.

In either embodiment, the wireless device is incorporated as a standardstep of manufacturing and no additional step in making the bag isrequired in order to incorporate the device into the bag.

Optionally, the wireless device is formed of materials that allow it tobe gamma compatible, thereby allowing the assembled container to begamma irradiated for sterility.

The wireless device can be either a read only device, telling the useronly that information which has been loaded on to it by themanufacturer, or preferably it is a read/write device allowing the userto add additional trackable events such as date of use, contents addedto the container, etc.

In one preferred embodiment the wireless device is always placed in thesame relative location from container to container for ease of use bythe user. For example by having the wireless device in the same spot,one could attach a reader in a location such as on ancillary equipmentor container holders that allows for the automatic interrogation of thedevice each time a new container is used.

It is an object of the present invention to provide a process forincorporating a wireless device permanently into a disposable containercomprising the steps of selecting a wireless device having a memory, anantenna and a communications component, the wireless device being formedas a single entity, providing plastic components for making a containerand incorporating the wireless device into the components such that thewireless device is permanently sealed into the container as it isformed.

It is an object of the present invention to provide a process forincorporating a wireless device permanently into a disposable containercomprising the steps of selecting a wireless device having a memory, anantenna and a communications component, the wireless device being formedas a single entity, providing plastic components for making a containerwherein the plastic components are at least two films of plastic havingcorresponding and matable edges that are capable of being fluid tightlysealed to each other and the wireless device is placed between thematable edges and retained there before or during the sealing of thematable edges to each other such that the wireless device is permanentlysealed into the container as it is formed.

It is an object of the present invention to provide a process forincorporating a wireless device permanently into a disposable containercomprising the steps of selecting a wireless device having a memory, anantenna and a communications component, the wireless device being formedas a single entity, providing a plastic component to be mated and sealedto the container, incorporating the wireless device into the plasticcomponent, attaching and sealing the plastic component containing thewireless device to the container in a desired location such that thewireless device is permanently sealed to the container.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a planar view of a bag according to the first embodiment ofthe invention.

FIG. 2 is a cross sectional view of the embodiment of FIG. 1.

FIG. 3 shows a typical wireless device useful in the present inventionin planar view.

FIG. 4 is a planar view of a bag according to the second embodiment ofthe invention.

FIG. 5 is a cross sectional view of the embodiment of FIG. 4.

FIG. 6 is close-up planar view of a corner of a container according toone embodiment of the present invention.

FIG. 7 is a flow diagram illustrating a first preferred embodiment ofthe process of this invention.

FIGS. 8A and B are flow diagrams illustrating additional preferredembodiments of the process of this invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS

FIG. 1 shows a disposable container 2, in this embodiment a plasticflexible container or bag, formed of one or pieces of film 4 havingopen, adjacent edges 6 which are fluid tightly sealed together to form aclosed container 2. In the embodiment shown, two pieces of film 4 areused and are in the form of sheets of similar sizes. The two sheets offilm 4 are placed adjacent each other, preferably directly touching eachother at least along the respective edges 6 to be sealed.

A wireless device 8 is placed between the edges to be sealed and thenthe edges are fluid tightly sealed together trapping the wireless devicebetween them. The device 8 may contain information such as date ofmanufacture, container manufacturer, container type, catalog number,serial number etc. This may either be loaded onto the device 8 before itis inserted between the edges 6 to be sealed or after it is sealed inplace. If desired the device may have an adhesive or adhesive padattached to at least one surface for temporarily securing the device tothe film during the sealing of the film. In this way, the device is notlost or moved during assembly.

FIG. 2 shows a cross-sectional view of the embodiment of FIG. 1. As canbe seen the device 8 is contained between the two edges 6 of the film 4so that the device 8 is permanently sealed into the container 2 but isisolated from both the container interior and the outside environment.This allows the device to be used and yet not be in contact with thecontents of the container in case there may be adverse effect to eitherthe contents or the wireless device by such contact. Additionally, thedevice is permanently affixed to the container and remains with itthroughout its life so that data is never lost or compromised. Likewiseby isolating it from the outside environment it is protected from dust,liquids and other effects that might otherwise compromise its integrity.

The wireless device essentially comprises two components as shown inFIG. 3, a microchip or other memory type of device 100 and an antenna102. These are generally attached to a plastic surface or sheet 104 orencapsulated with an epoxy (not shown). The antenna can be a cut orpunched metal array, a screen printed design or any other type ofantenna common to these devices. The device can be of any frequencyalthough high frequency (HF) and ultrahigh frequency (UHF) are the mostpopular. Additional elements may be added if desired such as a batteryor capacitor to provide the device with its own power source (notshown). Most systems however are passive and rely on the signal from thereader/writer to power up the device as needed. Such passive circuitshave been constructed from thermally stable materials such as Tagsys SDMRFID tags or Datalogic RFID tags made with polyimide support film (seeWO1999019851 A1). These tags are designed and have been shown to survivethermal molding processes compatible with thermal container assemblytechniques.

In many applications, the containers are sterilized and remain sterileat least until use. These containers are often irradiated with beta orgamma radiation to render them sterile. Unfortunately for the largemajority of wireless devices the memory and other components are notradiation compatible as they use a stored charge to represent the valueof each binary bit of data. Such devices are highly susceptible tocorruption caused by the radiation. Often the charge is depleted orenhanced by the radiation, thereby affecting its value and the data thatmay be contained within it. Such devices include but not limited toFlash memory such as EEPROM, DRAM and SRAM.

There are other memory technologies that use mechanisms other thancharge storage to retain data and values of a bit. For example, FRAM orferro-magnetic RAMs, utilize molecules having a bi-stable structure tostore state, wherein the one of the stable molecular configurationsrepresents a high or ‘1’ and the other represents a low or ‘0’. Severalcommon molecules in a FRAM are PZT (lead-zirconate-titanate), SBT(Strontium-bismuth-tantalate) and BLT (lanthanum-substitutedbismuth-tantalate). Each possesses a central atom in a cubic unit cellhaving a dipole moment. The molecules switch between these two stablestates based on the application of an electric field to the molecule.Since these cells rely on electrical fields, rather than storage charge,memories utilizing this mechanism are far less susceptible to gamma andother types of radiation than traditional semiconductor memorystructures and are described in U.S. Pat. No. 3,728,694.

Another example of a memory device that does not utilize charge as thestorage mechanism is MRAM, also known as magnetoresistive or simplymagnetic RAM. These devices use ferromagnetic materials often in theform of Hall sensors to store the state of the bit. See U.S. Pat. No.6,140,139. Since the magnetic fields are utilized instead of thecapacitive charge these devices are also less susceptible to radiationespecially gamma radiation.

Any other device that uses a system that is not susceptible to radiationmay also be used in such embodiments.

The wireless device(s) 8 can be any such device such as a RFID tag, aZigbee® device, a Bluetooth® device and the like as is known to the art.

By “fluid tightly”, it means the container seals are liquid tightlysealed and are sealed to an extent that air or gas is not detected asleaking through the film seal area. Of course depending upon the filmmaterial selected some gas may eventually transfer interstically eitherfrom inside the container to the environment or from the environmentinto the container and the term is meant to allow for that happen if thefilm selected is not highly gas impervious. The use of gas imperviousplastics such as EVOH can reduce or eliminate this transport of gasacross the container wall and it is meant by the term to cover thataspect as well.

FIG. 4 shows a second embodiment of the present invention. Suchcontainers (be they bags or rigid containers) need one or more plasticcomponents 10 such as ports, tubing nipples, hanging eyelets, alignmentplates and the like molded or sealed to them to allow for otherfunctions such as the entry and exit of various components such asproduct to be stored, worked on, etc, processing liquids such as water,cell culture media if a bioreactor bag, gases such as oxygen, carbondioxide, nitrogen, etc and the like or to provide means for hanging oraligning the container in a desired arrangement. These plasticcomponents such as the ports 10 (as shown) are generally formed of aflange portion 12 that is sealed to the container 2. In the case of aport 10 the flange portion 12 is around an opening 18 (FIG. 5) in thecontainer wall. In this embodiment, a stem 14 extends away from theflange portion of the port 10 and as shown is attached to a tube 16 orother such element. Other elements can include but are not limited tofilters, sterile connectors and the like. Alternatively, the plasticcomponent may be a grommet or rivet-like structure having twoessentially similar pieces that are sealed together or it may only haveone plastic portion that attaches to the surface.

A wireless device 8 is attached to a portion of the plastic component10. As shown in FIGS. 4 and 5 the device 8 is attached to the flangeportion 12 of the plastic component 10. This may be by being molded intothe flange portion or by heat sealing it to a portion of the port or byadhering it to the desired portion of the port as desired. Preferably,it is molded into a portion of the port itself so as to isolate it fromthe contents of the container and protect it from the environment andaccidental damage during storage, shipping or use. Alternatively, it maybe located on a portion of the port where it is isolated from thecontainer contents simply by its location. Such positions include butare not limited to the interface between the flange 12 and the innersurface of the container 2 to which the flange 12 is attached and theouter surface of the stem 14 (preferably in the area covered by the tube16 to further isolate and protect it from the environment.

It is desirable in some applications to have the wireless device mountedin the same relative location from container to container so that a userdoes not need to search for the device. Additionally, this isparticularly useful in applications where the scanner is mounted on anancillary piece of equipment. In one embodiment, it is mounted to theinlet port of the container. In another, it is located at the left,right or center of the uppermost seam. Some containers use eyelets 20and other devices to hold them upright or to align them duringinstallation or use (FIG. 6). Such structures are another good locationfor the wireless devices 8 as they also can help orient the container tothe user ensuring it always goes in the correct way and in the properalignment. In a further embodiment, the wireless device may be highlycolored or the plastic component to which it is attached is highlycolored (not shown) so that it is easily found. Other similar locationsmay also be used.

The disposable container of this invention is formed of a polymericcomposition such as polyethylene, including ultrahigh molecular weightpolyethylene, linear low density polyethylene, low density or mediumdensity polyethylene; polypropylene; ethylene vinyl acetate (EVOH);polyvinyl chloride (PVC); polyvinyl acetate (PVA); ethylene vinylacetate copolymers (EVA copolymers); blends of various thermoplastics;coextrusions of different thermoplastics; multilayered laminates ofdifferent thermoplastics; or the like (by different it is meant toinclude different polymer types such as polyethylene layers with one ormore layers of EVOH as well as the same polymer type but of differentcharacteristics such as molecule weight, linear or branched polymer orfillers and the like). Typically medical grade and preferablyanimal-free plastics are used. The container maybe a flexible plasticcontainer such as a bag or a rigid plastic container such as a bin, box,tote, barrel and the like. They may be sterilized such as by steam,ethylene oxide or radiation, such as beta or gamma radiation. Most havegood tensile strength, low gas transfer and are either transparent or atleast translucent.

In use, the wireless devices 8 are read by a scanner (not shown) whichmay be a fixed station such as a desktop reader like the AccuSmart™reader available from Millipore Corporation of Billerica, Mass. or ascanner mounted to either a holder for the container, such as bin ortote, if used, or an ancillary piece of equipment such as a pump or thelike (not shown), or a hand held device such as the Hose Tracker™ readeravailable from Advantapure of South Hamilton, Pa.

The wireless device may be a read only device so that it contains onlyinformation loaded by the manufacturer at its facility. In use, thewireless device 8 arrives at a user's facility with manufacturer name,container type or use restrictions and sterilization data, etc. alreadyloaded on to it or contained on a secure website of the manufacturerwhich can be accessed by providing the website with the identificationnumber contained on the wireless device. Also with read only wirelessdevices one can use a computer, local or wide area network or internetsite to track what happens to the container in the hands of the user bylisting one or more trackable events (type of use, date of use,contents, etc) on the computer, network or internet site using theidentity code assigned to the wireless device.

Preferably, the device 8 is a read/write device capable of addingadditional information by the user. This information may be an identity(unique user code or specific user use) or location of the bag oroptionally, at least one trackable event such as its date ofinstallation, installer, contents, etc. This information may be enteredby the scanner and also read by the scanner. The information may bestored on the wireless device itself and it may be downloaded to acomputer or network connection or the internet if desired.

The device 8 may be a passive device being active only when beingscanned or interrogated by the reader. Alternatively, it may be anactive device and either contain a battery for power or be coupled suchas by a magnetic inductive system to a power source.

For storage applications, the device 8 or the computer network orinternet site may contain specific storage instructions such astemperature to be maintained at, length for storage and the like.

To make a product containing a wireless device as claimed in thisinvention, for a plastic bag, one takes one or more pieces of plasticfilm, preferably two or more pieces, as shown as step 30 in FIG. 7,places the wireless device on a portion of the film(s) to be sealed asin step 32 and seals the desired edges of the film(s) together such asby heat sealing or glue or adhesives, or sonic vibration, as in step 34.

In incorporating the wireless device to a plastic component 10, such asa port one follows the procedure of FIG. 8A or FIG. 8B.

In FIG. 8A the wireless device is incorporated into the plasticcomponent in step 40. This may be done such as by molding the device 8into the component as it is made. In step 42 the component containingthe wireless device 8 is then sealed to the container 2.

In FIG. 8B, the component is made and then the wireless device isassociated with it. This can be done by overmolding the device to thecomponent or by adhering it to the component. Alternatively, the devicecan be placed on the container surface and covered by the component asit is sealed to the container.

A system according to any of the embodiments allows one toelectronically collect and/or store one or more trackable events such asdata relating to the container, its installation, use and if done,testing results.

The wireless device enabled system of the present invention eliminatesany error as to location, date, time, user and the like and allows oneto use good manufacturing practices (GMP) and good laboratory practices(GLP) in sampling systems.

EXAMPLE 1

A wireless device, in this example a RFID tag formed of read/write chipand an antenna, available from Tagsys S.A. of France as catalog itemArio™ SM-ISO RFID tag was selected for this example. The wireless devicehad dimensions of 14 mm wide by 14 mm long and 2 mm high.

Two sheets of a polyethylene based plastic film (Pureflex™ filmavailable from Millipore Corporation) were selected.

The wireless device was tested before insertion between the sheets byreading the device with a handheld reader available from Tagsys.

The device was centered between the two sheets and the edges of thesheets around the device were heated sealed using a hot iron at 180° C.with hand pressure to simulate a seam in a biobag.

The sheets were allowed to cool and the wireless device was then testedand found to be capable of both reading and writing information.

EXAMPLE 2

A wireless device, in this example a RFID tag formed of read/write chipand an antenna, available from Tagsys S.A. of France as catalog itemArio™ SM-ISO RFID tag was selected for this example. The wireless devicehad dimensions of 14 mm wide by 14 mm long and 2 mm high.

The wireless device was tested before insertion into the housing byreading the device with a handheld reader available from Tagsys.

A circular piece of polypropylene was injection molded to encapsulatethe wireless device within the polypropylene.

An outer surface of the piece was placed against a polyethylene basedfilm (Pureflex™ film from Millipore Corporation) and bonded to the outersurface of the film by heating the film and circular piece with standardvibration thermal welder at about 200° C. for a period of approximately1 minute while applying pressure between the two. The vibration was thenstopped, the film and piece allowed to cool and the wireless device wasthen tested and found to be capable of both reading and writinginformation.

The invention claimed is:
 1. A disposable plastic container comprising:a read/write wireless device capable of having data written to theread/write wireless device including a memory, an antenna, and acommunications component; and a plastic component mated and permanentlysealed to said disposable plastic container, the plastic componentperforming a function for the container, facilitating entry and/or exitof components or providing means for hanging or aligning the containerin a desired arrangement, wherein said read/write wireless device isdisposed between said plastic component and said container such thatsaid plastic component covers said wireless device, such that saidplastic component is permanently sealed to said container, and saidwireless device is sealed between said plastic component and saidcontainer and is isolated from both interior and exterior environmentsof said container, herein said plastic component is selected from thegroup consisting of tubing nipples, ports, hanging eyelets, alignmentplates and grommets.
 2. The disposable plastic container of claim 1,wherein said plastic component is selected from the group consisting ofports and alignment plates.
 3. The disposable plastic container of claim1, wherein said plastic component is a port having a flange portionsurrounding an opening in said container.
 4. The disposable plasticcontainer of claim 1, wherein said wireless device is formed ofmaterials that allow it to be beta and gamma radiation compatible. 5.The disposable plastic container of claim 1, wherein said wirelessdevice is heat sealed to said plastic component prior to said attachingand permanently sealing.
 6. A system for automated handling ofdisposable plastic containers comprising: a scanning device; and aplurality of disposable plastic containers, each disposable plasticcontainer comprising: a read/write wireless device capable of havingdata written to the read/write wireless device including a memory, anantenna, and a communications component, said read/write wireless devicecapable of being interrogated by said scanning device; and a plasticcomponent mated and permanently sealed to said disposable plasticcontainer, the plastic component performing a function for thecontainer, facilitating entry and/or exit of components or providingmeans for hanging or aligning the container in a desired arrangement,wherein said read/write wireless device is disposed between said plasticcomponent and said container such that said plastic component coverssaid wireless device, such that said plastic component is permanentlysealed to said container, and said wireless device is sealed betweensaid plastic component and said Container and is isolated from bothinterior and exterior environments of said container; wherein saidwireless device and said plastic component are located in the samerelative location for each container of said plurality of disposableplastic containers, and wherein said plastic component is selected fromthe group consisting of tubing nipples, ports, hanging eyelets,alignment, plates and grommets.
 7. The system of claim 6, wherein saidscanning device is a hand held device.
 8. The system of claim 6, whereinsaid scanning device is mounted to a holder for said plurality ofdisposable containers.
 9. The system of claim 6, wherein said pluralityof disposable containers are aligned using an eyelet integrated intosaid container.
 10. The system of claim 6, further comprising acomputing device in communication with said scanning device, whereinsaid computing device allows for electronic tracking of events relatedto said plurality of containers.
 11. The system of claim 10, whereinsaid events include data relating to testing results for said pluralityof containers.